VAX-31在曾接种过肺炎球菌疫苗的≥50岁成人中的安全性、耐受性和免疫原性
一项评估 VAX-31 在 50 岁及以上曾接种肺炎球菌疫苗的健康受试者中安全性、耐受性和免疫原性的 3 期、随机、双盲、活性对照临床研究
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Arizona
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Chinle、Arizona、美国、86503
- Chinle Center for Indigenous Health
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Phoenix、Arizona、美国、85044
- Avacare (CCT Research)
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Whiteriver、Arizona、美国、85941
- Whiteriver Center for Indigenous Health
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Connecticut
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Waterbury、Connecticut、美国、06708
- Chase Medical Research
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Florida
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Hollywood、Florida、美国、33024
- CenExel (RCA)
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Jupiter、Florida、美国、33458
- Eximia (Health Awareness)
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Port Saint Lucie、Florida、美国、34952
- Eximia (Health Awareness)
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Sunrise、Florida、美国、33351
- Precision Clinical Research
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The Villages、Florida、美国、32162
- The Villages
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Georgia
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Stockbridge、Georgia、美国、30281
- DelRicht Clinical Research
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Indiana
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Valparaiso、Indiana、美国、46383
- Velocity Clinical Valparaiso
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Kansas
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Lenexa、Kansas、美国、66219
- Johnson County Clin-Trials, LLC
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Louisiana
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New Orleans、Louisiana、美国、70115
- DelRicht Clinical Research
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Maryland
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Rockville、Maryland、美国、20854
- Velocity (Meridian Clinical Research)
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Michigan
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Southfield、Michigan、美国、48076
- DM Clinical Research-Detroit
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Missouri
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Kansas City、Missouri、美国、64114
- AMR
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Springfield、Missouri、美国、65807
- DelRicht Research (Command Family Medicine)
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Nebraska
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Omaha、Nebraska、美国、68114
- Quality Clinical Research
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New Mexico
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Gallup、New Mexico、美国、87301
- Center of American Indian Health
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Shiprock、New Mexico、美国、87420
- Shiprock Center for Indigenous Health
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New York
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Rochester、New York、美国、14609
- Rochester Clinical Research, Inc.
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North Carolina
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Wilmington、North Carolina、美国、28403
- Headlands (Trial Management Associates)
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Oklahoma
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Edmond、Oklahoma、美国、73013
- Tekton Research
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Tennessee
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Hendersonville、Tennessee、美国、37075
- DelRicht Research
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Texas
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Austin、Texas、美国、78745
- Tekton Research
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Beaumont、Texas、美国、77701
- REX Clinical Trials
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San Antonio、Texas、美国、78229
- Flourish Research
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Sugar Land、Texas、美国、77478
- DM Clinical Research
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Virginia
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Charlottesville、Virginia、美国、22911
- Alcanza (Charlottesville Medical Research)
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Newport News、Virginia、美国、23606
- Health Research of Hampton Roads, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
- Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed).
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- Willing to have blood samples collected and used for research purposes.
- Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
- Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
- Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria:
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Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
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Previous receipt of an investigational pneumococcal vaccine at any age.
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Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
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Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
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Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
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Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
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History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
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Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
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Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
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Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
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Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study.
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Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to ≤10 mg/day and ≥2 weeks of prednisone equivalent >10 mg/day).
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Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccination
• History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
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Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
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Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Cohort 1 (VAX-31): Prior PPSV23
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
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有源比较器：Cohort 1 (PCV20): Prior PPSV23
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
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实验性的：Cohort 2 (VAX-31): Prior PCV20
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
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有源比较器：Cohort 2 (PCV20): Prior PCV20
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
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实验性的：Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
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有源比较器：Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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报告征询局部不良事件（AE）的受试者百分比（注射部位发红、肿胀和疼痛）
大体时间：接种疫苗后最多7天
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接种疫苗后最多7天
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报告征集性系统性不良事件（发热、头痛、疲劳、肌肉疼痛和关节疼痛）的受试者百分比
大体时间：疫苗接种后最多7天内
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疫苗接种后最多7天内
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报告非主动不良事件（AE）的受试者百分比
大体时间：接种后最多31天
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接种后最多31天
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血清型特异性OPA几何平均滴度（GMT）
大体时间：VAX-31疫苗接种后1个月
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VAX-31疫苗接种后1个月
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血清型特异性OPA几何平均倍数升高（GMFR）较基线
大体时间：接种VAX-31疫苗后1个月
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接种VAX-31疫苗后1个月
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报告新发慢性疾病（NOCI）、需医疗处理的AE（MAAE）和严重不良事件（SAE）的受试者百分比
大体时间：疫苗接种后长达6个月
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疫苗接种后长达6个月
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次要结果测量
结果测量 |
大体时间 |
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血清型特异性IgG几何平均浓度（GMC）
大体时间：接种VAX-31疫苗后1个月
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接种VAX-31疫苗后1个月
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血清型特异性IgG从基线的几何平均倍数上升（GMFR）
大体时间：接种VAX-31疫苗1个月后
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接种VAX-31疫苗1个月后
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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